Study of EC0225 for the Treatment of Refractory or Metastatic Tumors
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This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.
Maximum tolerated dose (MTD) [ Time Frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients ]
Secondary Outcome Measures :
Pharmacokinetic and pharmacodynamic parameters [ Time Frame: Obtained during the first cycle of therapy on Days 1 and 3 ]
Anti-tumor activity [ Time Frame: Initial dose of study therapy to disease progression ]
Uptake of 99mTc-Ec20 in tumors and normal tissues [ Time Frame: 1-2 hours post-administration of 99mTc-EC20 ]
Safety and tolerability [ Time Frame: Initiation of study therapy through 30 day post last dose of study therapy ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
18 years of age or older
Histological or cytological diagnosis of neoplasm
No effective standard therapeutic options
ECOG performance status of 0-2
≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
Adequate bone marrow reserve, renal and hepatic function